RecruitingPhase 4ACTRN12614000542695

Does melatonin help children with Attention Deficit Hyperactivity Disorder (ADHD) sleep better?

Does melatonin reduce sleep onset latency compared to placebo in children with ADHD on stimulant medication?

Sponsor

The University of Queensland

Enrollment

300 participants

Start Date

Jun 2, 2014

Study Type

Interventional

Conditions

Insomnia ADHD

Summary

Methodology Randomised, Double-Blind, Placebo-Controlled, Multi-Centre trial of aggregated N-of-1 Trials compared to parallel group RCT on the Effects of melatonin on SOL in children and adolescents with ADHD who are receiving stimulant medication. Study Duration 6 weeks (3 pairs over a six week period) for each individual participant Objectives Hypotheses: 1) Melatonin is effective for alleviating initial insomnia in ADHD children who are receiving stimulant medication; and 2) N-of-1 trials provide a similar estimate of treatment effect with less uncertainty than a parallel group RCT. Objectives: 1) To determine the efficacy of melatonin in shortening sleep latency times in children with ADHD treated with stimulants 2) To determine whether n-of-1 trials provide similar estimate of treatment effect with less uncertainty than a parallel group RCT Number of Participants 300 participants (children), 300 parent/guardians from Queensland and Canada

Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

Many children with ADHD who take stimulant medication (like Ritalin or Concerta) have trouble falling asleep at night. This study is testing whether melatonin — a natural sleep hormone — can help these children fall asleep faster. Children will receive either melatonin or a placebo in a series of short treatment periods over six weeks, so researchers can see how well it works for each individual child. You may be eligible if: - Your child is between 6 and 17 years old - Your child has been diagnosed with ADHD - Your child has been on a stable dose of stimulant medication for at least one month - Your child takes at least 45 minutes or more to fall asleep, three or more nights per week You may NOT be eligible if: - Your child has autism, brain injury, cerebral palsy, uncontrolled depression, migraines, PTSD, psychosis, or a seizure disorder - Your child has untreated sleep apnoea, narcolepsy, or a related sleep disorder - Your child has a known allergy to melatonin or its ingredients - Your child takes immunosuppressants, blood pressure medications, SSRIs, or blood thinners - The parent or guardian does not speak English or does not have a phone Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study will use a randomised, double-blinded N-of-1 trial design comparing the effects of melatonin and placebo on reducing sleep latency in individual subjects. The intervention medication wil

This study will use a randomised, double-blinded N-of-1 trial design comparing the effects of melatonin and placebo on reducing sleep latency in individual subjects. The intervention medication will be immediate release melatonin taken orally 30 min before bedtime; 3 mg if child is under 40 kg, and 6 mg if child is equal to or over 40 kg. The comparator medication will be an equivalent placebo tablet, containing cellulose. Each participant will undergo three treatment periods, consisting of one week of melatonin and one week of placebo in randomized order, for a total of 6 weeks. The first day of data from each week will be discarded to allow for washout. Adherence will be monitored by pill counts at the end of the trial.